completing the first phase of its $51.9 million contract with US government’s BARDA

London, UK and Carlsbad, CA, USA – 2 November 2018 – A rapid new diagnostic platform that harnesses the power of semiconductor DNA sequencing, promises to revolutionise the ability of physicians to treat antimicrobial resistant infections.

DNA Electronics (‘DNAe’), the company behind the platform, today announces that it has successfully completed the first phase of its contract that could be worth up to $51.9 million, with U.S. government agency, the Biomedical Advanced Research and Development Authority (BARDA)*. The contract, initially awarded in September 2016, supports the development of DNAe’s next generation sequencing (NGS) platform for rapid diagnosis of antimicrobial resistant infections and influenza. BARDA has already approved the next stage of the contract, which is currently underway.

Using technologies that will ultimately be suitable for a rapid user-friendly test, DNAe has successfully sequenced the DNA of bacteria directly from an unprocessed blood sample. This has not been possible with any sequencing technologies to date, which have typically entailed long turnaround times and been relegated to specially-trained users in sophisticated labs. This breakthrough will enable hospitals to precisely identify the infectious agent and any resistance to antibiotics. This intelligence is vital, helping physicians choose targeted treatments that will be most successful in treating the infection.

“This will help to address the increase in antimicrobial resistance by fundamentally changing the way antibiotics are prescribed” said Professor Chris Toumazou, the inventor of semiconductor sequencing technology, DNAe’s Executive Chairman and Regius Professor of Engineering at Imperial College London (Department of EEE). He added “The relative speed, simplicity, scalability and cost-effectiveness of semiconductor sequencing allow it to be used in a much wider range of settings than previously possible for DNA sequencing, and make it particularly suited to application in diagnosis.”

Sam Reed, President, U.S. Office said: “We have completely redesigned the DNA sequencing process to allow it to be used for rapid diagnosis in hospitals, closer to the patient, and operated by users who are not specially-trained. It’s a completely different type of workflow than has been used before, so successfully achieving this latest milestone was a real ‘eureka moment’. We now have proof that this new approach works – all we need to do is integrate the steps into one box. BARDA’s support is enabling us to fast track this program and address the global crisis of antimicrobial resistance.”

BARDA has already approved DNAe to progress to the second phase of the contract, releasing $10.98m for the development of an alpha prototype. DNAe has also increased its engagement with clinicians and end users, having brought on board an expert clinical advisory board in 2017.

Each year in the United States alone, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.1 In addition, across Europe, an estimated 25,000 people die each year as a result of hospital infections caused by antibiotic resistant Escherichia coli, Klebsiella pneumoniae, Enterococcus faecium, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus (MRSA), adding over £1 billion to hospital treatment and societal costs. The problem is getting worse and unless tackled antibiotic resistance could result in 10 million deaths per year globally by 2050, costing an estimated £66 trillion.2

Dr Steve Allen, CEO DNAe Group Holdings commented, “Our next-generation sequencing-based diagnostic platform has been carefully designed with the end users in mind, and we have been interacting with clinicians from the outset to get feedback at every stage of development to make sure it meets their needs. We are realising our vision of bringing DNA sequencing into the clinic, so that patients can really benefit from its accuracy and speed of diagnosis which should make such a difference to getting the most effective treatment to patients.”

DNAe’s genomic analysis technologies are based on its invention of semiconductor DNA sequencing, a specific type of next-generation sequencing that works by using a silicon chip to detect the ions released as a DNA strand is built up molecule by molecule. DNAe has three new patent applications from the first phase of the project alone.

Professor Chris Toumazou concluded that, “Bringing genomics and DNA sequencing closer to the patient will transform the treatment pathway by arming doctors with the information that they need to make an evidence-based treatment decision. The continued support of BARDA will be instrumental in our mission to provide rapid diagnostics to support healthcare professionals globally.”

*BARDA is a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® launches with the LiDia® Bloodstream Infection (BSI) test, a ground-breaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and pandemic influenza.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 16 October 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, was named ‘Best Diagnostic Medtech Company’ at the 2018 OBN Awards.

Marking its 10th anniversary, the prestigious OBN Awards recognize and celebrate innovation and achievement of leading companies in the Life Sciences industry.

DNAe was chosen by a panel of independent expert judges, representing a diverse spectrum of UK and global life sciences stakeholders. DNAe beat the other finalists, Oxford Cancer Biomarkers, Owlstone Medical and Inivata, to the award. DNAe was recognized for its pioneering semiconductor DNA analysis and sample preparation1 technologies that underlie its breakthrough direct-from-blood, cartridge-based diagnostic in development, LiDia® BSI1,2, as well as the developmental progress and disruptive potential of the LiDia® BSI method.

Jonathan Rohll, Head of Business Information at OBN said: “DNAe really caught the eye of many of our judges for addressing a clear unmet need with their novel microchip-based, fast and simple technology platform that has huge potential in the early diagnosis of sepsis and other acute conditions. We would like to congratulate them on winning the Best Diagnostic Medtech Company category at the 2018 OBN Awards.”

Accepting the award at the OBN Awards ceremony on 11 October at the Examination Schools of the University of Oxford, Oxford, UK, were Nick McCooke, Chief Business Officer of DNAe, and Dr Nour Shublaq, DNAe’s European Product Manager. McCooke said: “We are very proud to be named as Best Diagnostic MedTech Company at the 2018 OBN Awards. Identification of bloodstream infections using current standard-of-care culture-based diagnostics is slow, and testing is often carried out at specialist laboratories away from the patient. Meanwhile, treatment is typically empirical, impacting survival rates and hospital stay negatively. DNAe’s first generation platform and revolutionary test, currently in development, will enable rapid diagnosis of sepsis-causing bloodstream infections closer to the frontline of care, and operated by non-expert end users. The potential impact to patients and institutions from timely evidence-based treatment owing to our approach is considerable.”

DNAe’s first generation platform utilizes amplification-based detection. The LiDia® BSI test promises to revolutionize the ability of physicians to treat antimicrobial resistant infections by identifying the causative pathogen, including key antimicrobial resistance markers within two to three hours, directly from a whole blood sample.

DNAe’s Executive Chairman, Professor Chris Toumazou, co-inventor of several DNA semiconductor technologies used in the platform, and Regius Professor of Engineering at Imperial College London, commented: “This is another outstanding achievement underscoring our innovative technologies, determination and inspirational efforts to transform bloodstream infection diagnosis with fast and simple semiconductor-based diagnostics.”

Dr Steve Allen, CEO of DNAe Group Holdings commented: “We are delighted that DNAe is named as Best Diagnostic MedTech Company at the 2018 OBN Awards and we thank the Expert Judges for this special honor. Being recognized in short order in two separate prestigious industry award programs, now by the OBN Awards and last month by the MedTech Insight Awards, follows a successful first half of the year for DNAe. In April, at the ECCMID 2018 congress, we previewed a demonstration of the blood-to-result workflow of LiDia® BSI for the first time at our booth, and presented data that demonstrated the ability of the LiDia® BSI method to detect pathogens and antibiotic resistance in samples from patients who had received antibiotic therapy, within a significantly shorter period than standard-of-care blood culture testing. We look forward to making further announcements in due course.”

Last month, DNAe was also named ‘Most Innovative Team or Innovator of the Year’ at the Inaugural Medtech Insight Awards in Philadelphia, USA. More details can be found, here.

References

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

Test in development. For Research Use Only. Not for use in diagnostic procedures.

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 27 September 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, was named ‘Most Innovative Team or Innovator of the Year’ at the inaugural 2018 Medtech Insight Awards.

The Most Innovative Team or Innovator of the Year award recognizes the medical technology team that has contributed most significantly to the device and diagnostic space between 1 January 2017 and 31 May 2018. DNAe beat the other finalists, electroCore, Eyenovia, Innoventions, MediSieve, Owlstone Medical, PolarityTE, and The Trendlines Group Labs Team to the award. DNAe was chosen by the expert judges for its development achievements during the qualifying period and towards realizing a rapid, user-friendly, direct-from-sample diagnostic platform based on its semiconductor sequencing technology1.

DNAe, a spin-out of Imperial College London, fundamentally redesigned DNA sequencing from the ground up, using novel technologies that will be suitable for rapid diagnosis closer to the frontline of care and operable by non-specialist end users. The Company was judged to be the high performing team that has been most successful in reaching its goals, adopted innovative working practices, achieved major milestones within expected timelines, and contributed to the advancement of medical technology for unmet medical needs.

Accepting the award at the Medtech Insight Awards ceremony on 23 September at the Kimpton Hotel Monaco in Philadelphia, USA, Sam Reed, Program Director and President of DNAe’s U.S. Office, said: “Winning this award is a great honor, and a testament to our whole team’s dedication and performance. The ultimate goal is to enable sequencing to solve urgent unmet clinical needs, including antimicrobial resistance and influenza. We strongly believe that innovation is fundamental to achieving our mission to enable DNA sequencing to be used in hospitals, much closer to the frontline of care than it is used today.”

DNAe’s sequencing-based diagnostic platform promises to revolutionize the ability of physicians to treat antimicrobial resistant infections by rapidly identifying the infectious agent including any antimicrobial resistance. This has potential to enable swifter treatment of infections with targeted therapeutics to improve patient outcomes and address a critical unmet need.

DNAe’s sequencing platform in development is funded in part by the Biomedical Advanced Research and Development Authority (BARDA)1, who awarded DNAe a contract worth up to $51.9 million, if all options are exercised, to develop its next generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “The first two years of our contract with BARDA to develop a rapid, user-friendly, direct-from-sample diagnostic sequencing platform have been highly productive. We are delighted that our technologies and the inspirational thinking of our talented scientists and engineers have been recognized with this prestigious award.”

In parallel to its next-generation sequencing based platform, DNAe is developing a diagnostic which uses DNA amplification (PCR) and semiconductor technology, to detect pathogens and key resistance markers. Also operating directly from blood, this first-generation system will provide actionable results within 2-3 hours. The test, called LiDia® Bloodstream Infection (BSI)2,3, has the potential to transform the management of sepsis.

Professor Chris Toumazou, inventor of DNAe’s semiconductor sequencing technology, DNAe’s Executive Chairman and Regius Professor of Engineering at Imperial College London (Department of EEE) added, “Bringing genomics and DNA sequencing for rapid diagnosis closer to the patient will transform the treatment pathway by arming doctors with actionable information that they need to make a timely, appropriate, and evidence-based treatment decision. I am delighted that our achievements and potential have been recognized in this award.”

The Medtech Insight Awards Judging Panel commented, “DNAe is developing a next-generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza. An outstanding advancement in one of the most critical health issues today. The organized teamwork, with multi-disciplinary expertise, is very impressive. This company has accomplished a great deal.”

1 This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.

2 Test in development. For Research Use Only. Not for use in diagnostic procedures

3 This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

August 15, 2018 | DNAe Chosen as Best Diagnostic Medtech Company Finalist in the 2018 OBN Awards

DNAe Chosen as Best Diagnostic Medtech Company Finalist in the 2018 OBN Awards

London, UK and Carlsbad, CA, USA – 15 August 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, today announced that it has been shortlisted as a finalist for the 2018 OBN Awards, in the category ‘Best Diagnostic Medtech Company’. These prestigious industry award nominations recognise and celebrate leading companies in the Life Sciences industry.

The finalists were judged by a panel of independent experts, representing a diverse spectrum of UK and global life sciences stakeholders.

DNAe has been selected for its pioneering semiconductor-based genomic analysis and sample preparation1 technology platforms that underlie its game-changing diagnostic in development, LiDia® BSI1,, which is a rapid direct from blood test for bloodstream infections (BSI) that can lead to sepsis. DNAe’s LiDia® BSI1,2 diagnostic promises to revolutionise the ability of physicians to treat antimicrobial resistant infections by rapidly identifying the infectious agent including key antimicrobial resistance markers within 2 to 3 hours, directly from sample presentation.

Sepsis is a major global healthcare priority, with an estimated 31.5 million bloodstream infection cases occurring annually worldwide, resulting in approximately 5.3 million deaths3. In the US and Europe, sepsis is responsible for an estimated 2.5 million cases4, and in the US, sepsis is the most expensive condition to treat accounting for nearly $27 billion annual cost to the healthcare system5. In 2017, the WHO adopted a resolution on improving the prevention, diagnosis and management of sepsis6.

For every hour a patient in septic shock does not receive the appropriate antibiotic, there is an 8% reduction in survival rate7. Pathogen identification using current standard-of-care culture-based diagnostics takes 2-6 days and involves sending samples offsite to specialist laboratories, during which time patients typically receive empirical treatment impacting survival rates and hospital stay negatively. Designed to be used in hospitals, much closer to the frontline of care and operated by non-specialist end users, LiDia® BSI has the potential to enable swifter treatment of infections with targeted therapeutics to improve patient outcomes and address a critical unmet need.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “We are delighted to receive recognition from the Life Sciences industry as a Best Diagnostic MedTech Company finalist, and we are tremendously proud that DNAe has been shortlisted for two prestigious awards in short order8. These nominations help shine light on our key advances to the diagnostic field, and are a testament to our innovative technologies as well as the commitment and excellence of our entire team. We’re developing LiDia® BSI to address the pressing demand for earlier diagnosis of bloodstream infections in hospitals closer to the patient, and assisting swifter evidence-based selection of targeted treatment.”

Dr John Harris, CEO of OBN (UK) said: “We received the highest number of qualifying entries for the OBN Awards this year, up a staggering 40% on last year’s total. The standard of entries across all categories was extremely high and we are encouraged about the level of exciting new innovation and positive growth we are seeing in UK Life Sciences. We look forward to celebrating with all our finalists on 11 October at the Examination Schools in Oxford.”

A panel of independent expert judges will further assess the finalists for each category and the winners will be announced on 11 October at the OBN Awards ceremony in Oxford, UK. The occasion also marks the 10th Anniversary of the OBN Awards, celebrating 10 years of Innovation and Achievement in the Life Sciences Industry.

The full list of award categories and finalists can be found online, here.

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

1This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

2Test in development. For Research Use Only. Not for use in diagnostic procedures.

August 8, 2018 | DNAe Named as Top Innovator Finalist in the Inaugural 2018 Medtech Insight Awards

DNAe Named as Top Innovator Finalist in the Inaugural 2018 Medtech Insight Awards

London, UK and Carlsbad, CA, USA – 8 August 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, today announced that it has been shortlisted for the inaugural 2018 Medtech Insight Awards, in the category ‘Most Innovative Team or Innovator of the Year’.

The finalists were judged by a panel of independent experts, who are highly regarded within the medtech sector. DNAe was selected in recognition of its development achievements in the qualifying period 1 January 2017 - 31 May 2018, and towards realizing a rapid, user-friendly, direct-from-sample diagnostic platform based on its semiconductor sequencing technology.1

Each year in the US, at least two million people become infected with bacteria resistant to antibiotics and at least 23,000 people die2. The problem is getting worse and unless tackled, antibiotic resistance could result in ten million extra deaths each year and cost the global economy an estimated $100 trillion by 20503. Pathogen identification using current standard-of-care culture-based diagnostics is slow. Patients typically receive empirical treatment, given without knowledge of the underlying cause of their illness, impacting survival rates and hospital stay negatively.

The DNAe platform in development will be used in hospitals, much closer to the frontline of care than sequencing is used today, for a range of urgent clinical applications. It is funded in part by the Biomedical Advanced Research and Development Authority (BARDA)* who awarded DNAe a contract worth up to $51.9 million, if all options are exercised, to develop the next generation sequencing platform for rapid diagnosis of antimicrobial resistant infections and influenza.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “We are extremely proud to be chosen as one of the top medical technology innovators of 2018. We are delighted that the technologies we have invented, and the inspirational thinking and diligence of our talented scientists and engineers have come together to deliver this success. Diagnostics are a key part of the solution to tackling the growing global health crisis of antimicrobial resistance. We are committed to transforming infectious disease diagnosis by redesigning DNA sequencing from the ground up to enable its use closer to the frontline of care.”

The Most Innovative Team or Innovator of the Year category recognizes high performing medical technology teams who have contributed significantly to the device and diagnostic space. The award winner will be the team deemed by the expert judges most successful in having reached its goals, adopted innovative working practices, achieved major milestones within expected timelines, and contributed to the advancement of medical technology for unmet medical needs.

The full list of Medtech Insight Award finalists can be found online, here. The winners will be announced at the award ceremony to be held on the evening of 23 September at the Kimpton Hotel Monaco in Philadelphia, USA.

In parallel to its next-generation sequencing based platform, DNAe is developing a diagnostic which uses DNA amplification (PCR) and semiconductor technology, to detect pathogens and key resistance markers. Also operating directly from blood, this first-generation system will provide actionable results within 2-3 hours. The test, called LiDia® Bloodstream Infection (BSI), has the potential to transform the management of sepsis.

*BARDA is part of the office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).

1This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Pathogen detected in 9 samples that were negative in the paired blood culture but confirmed with other microbiological data

Time from specimen collection to result for the LiDia® BSI method was just a few hours, compared to 2-5 days with blood culture

Study conducted in collaboration with Mayo Clinic and University New Mexico Health Sciences Center

London, UK and Carlsbad, CA, USA – 24 April 2018 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections (BSI) that can lead to sepsis, announces new data generated with its LiDia® Bloodstream Infection (BSI) technology, currently in development. The LiDia® BSI method was demonstrated to detect pathogen and antibiotic resistance in samples collected from patients after receiving antibiotic therapy. Time to detection by the LiDia® BSI method was significantly shorter (hours vs. days) compared to standard-of-care blood culture testing.

Early treatment with broad-spectrum antibiotics is critical for patients with BSIs. However, antibiotics can affect the growth of any bacteria present in a sample and can therefore lead to false negatives if blood culture is used for diagnosis once a patient has begun antibiotic treatment. The technology used by LiDia® BSI can detect the presence of pathogens without interference by antimicrobial therapy.

Pathogens and antibiotic resistance detected by the LiDia® BSI method in samples collected from patients with suspected or confirmed BSI showed concordance with blood culture results in 31 patients pre-treated with antibiotics. The LiDia® BSI method also detected pathogens in a further nine samples, where blood culture collected concurrently produced a negative result. The LiDia® BSI results in these samples matched earlier blood culture results from the same patients. Time to result for the LiDia® BSI method was just a few hours, whereas blood culture results were available 2-5 days after specimen collection.

Clinical specimens were collected with consent from two sites, the Mayo Clinic (Rochester, MN, USA) and the University of New Mexico Health Sciences Center (Albuquerque, NM, USA). The largest numbers of patients with positive blood cultures in the DNAe study came from the Medical Intensive Care Unit (MICU) (25%), surgical wards (20%) and general medical wards (17.5%), followed by Emergency Departments (ED) (12.5%). The most frequently encountered microorganisms were Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae.

Once a specific diagnosis is confirmed, patients can be treated with a more targeted antibiotic. Rapid and accurate identification of the pathogen would enable physicians to prescribe targeted treatment faster, potentially improving the patient’s prognosis and reducing healthcare costs. It could also help to reduce the spread of antimicrobial resistance by preventing the over-use of broad spectrum antibiotics.

David Davidson, Chief Scientific Officer at DNAe and author on the poster said, “The study demonstrates the real-world potential of LiDia® BSI, and its ability to rapidly identify infectious agents even in patients who are already being treated with antibiotics. The test could help clinicians determine if patients already being treated with antibiotics are on the correct drug and may enable treatment with targeted antibiotics to begin immediately. Faster and more tailored treatment with this test could have huge implications for patient care.”

The data were presented as a poster (#P1960) at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018. Whilst the data presented at ECCMID combined LiDia®’s core methodologies, prototype systems were on show at ECCMID, demonstrating the simple, rapid utility of the test, at the point-of-need.

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

April 13, 2018 | DNAe to Present New Data and Preview its Blood-to-Result Test for Bloodstream Infection at ECCMID 2018

DNAe to Present New Data and Preview its Blood-to-Result Test for Bloodstream Infection at ECCMID 2018

London, UK and Carlsbad, CA, USA –13 April 2018– DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new game-changing test for bloodstream infections that can lead to sepsis, announces that new data will be presented on its LiDia® Bloodstream Infection (BSI) test1,2, at the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Madrid, Spain, 21-24th April, 2018.

A demonstration of the blood-to-result workflow for LiDia® BSI will be previewed at DNAe’s booth at ECCMID.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “ECCMID comes at a pivotal time in our journey to bring this vital rapid diagnostic test to market. We are pleased to present key data and look forward to reaching more of the infectious disease community at the event this year. The congress gives us an excellent opportunity to showcase the LiDia® BSI closed cartridge-based test for the first time to a wide clinical audience at our stand, and to demonstrate its potential to support faster and more informed treatment of sepsis.”

DNAe is developing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® will launch with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

1Test in development. For Research Use Only. Not for use in diagnostic procedures

2This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400015C.

DNAe to Present New Data on LiDia™ BSI, its rapid blood-to-result diagnostic test at the Association of Molecular Pathology Annual Meeting

London, UK and Carlsbad, CA, USA – 7 November 2017 – DNAe, the inventor of semiconductor based genomic analysis technologies, and the developer of a new, game-changing test for bloodstream infections that can lead to sepsis will be presenting new data at the Association for Molecular Pathology (AMP) Annual Meeting 2017 in Salt Lake City, USA from the 16th to 18th November.

Poster Presentation – ID31

Title:Rapid Diagnosis of Bloodstream Infections Through Identification of Pathogens and Resistance Markers Directly from Whole Human Blood at 1 CFU/ml

Drs. Nicola Casali, Nour Shublaq and Francois Paillier will be available to discuss the data.

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “As we move our LiDia™ BSI rapid blood-to-result diagnostic test towards commercial launch, we are pleased to present, for the second year running, key data at the AMP Annual Meeting, one of the premier annual gatherings in the field of molecular diagnostics. This is an exciting time for DNAe as we prepare to CE mark LiDia™ BSI in 2018, to enable us to bring this urgently needed test to market.”

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS)

awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and pandemic influenza.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 18 November 2017 – DNAe, the inventor of semiconductor-based genomic analysis technologies, and the developer of a new, game-changing test for bloodstream infections that can lead to sepsis today announced new data on its test for bloodstream infections, LiDia® BSI. The data demonstrates the ability of the LiDia® BSI closed cartridge-based test to rapidly identify low levels of bacterial and fungal pathogens and resistance markers direct from whole blood, including an example of successful automation. The data were presented as a poster (ID31) at the Association for Molecular Pathology (AMP) Annual Meeting 2017 in Salt Lake City, UT, USA (16th – 18th November).

LiDia® BSI was used to accurately detect the most common pathogens linked to serious bloodstream infections, including the superbug methicillin resistant S. aureus (MRSA), less frequent pathogens that are often mistreated empirically, and important resistance markers. The authors of the poster at DNAe confirmed end-to-end functionality of the LiDia® BSI workflow, correctly identifying pathogens and resistance genes at 1 colony-forming unit per ml (CFU/ml). Total turnaround time was less than 5 hours, with current automation of the process expected to reduce the total process time down to less than 3 hours.

The poster presentation includes data on the automation of the LiDia® BSI workflow, used to correctly detect the pathogen, K. pneumoniae at 2.5 CFU/ml.

Currently, the standard of care for diagnosis of bloodstream infection is via blood culture, which can take two to six days to produce results. For serious bloodstream infections, which can lead to the life-threatening condition of sepsis, early diagnosis and administration of antimicrobials targeting the causative pathogen is the single most important factor in reducing mortality and morbidity. Reducing time to diagnosis from days to hours therefore has potentially lifesaving implications. On track for CE marking in 2018, LiDia® BSI will reduce unnecessary prescription of antibiotics by providing actionable results directing targeted treatment in just a few hours, direct from raw blood specimen.

Clinical specimens of MRSA and methicillin-sensitive S. aureus were correctly identified directly from whole blood via detection of S. aureus and the presence or absence of mecA/C, concordant with blood culture results of the samples.

David Davidson, Chief Scientific Officer at DNAe and author on the poster said, “It’s exciting to be able to clearly demonstrate the ability of LiDia® BSI to detect pathogens and antimicrobial resistance present even at low levels, directly from raw blood samples. We continue to process clinical samples with some representative data points presented at this year’s AMP.”

Professor Chris Toumazou, Founder and Executive Chairman at DNAe and author on the poster said, “We are pleased to share this outstanding dataset including an automated exemplar at low limits of detection. Through the eventual automation of the entire workflow, LiDia® BSI has huge potential to cut down time to diagnosis for patients with bloodstream infection. We look forward to sharing larger datasets from our ongoing clinical testing program.”

Dr Steve Allen, CEO of DNAe Group Holdings, commented: “These data provide evidence of the sensitivity, breadth of pathogen coverage, inclusion of resistance genes, and speed of the LiDia® platform and test offering. Presenting these data at the AMP 2017 Annual Meeting is an important stepping stone as we move swiftly towards commercialization of the LiDia® BSI test. The ability to generate robust data from blood within hours, compared to days, will be transformational for patients with bloodstream infection. The next stage in the development process will be to fully integrate the workflow into the cartridge-based test to allow the system to deliver clinically actionable results in less than 3 hours.”

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia®, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia® range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia® launches with the LiDia® Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and pandemic influenza.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 26 September 2017 – DNAe, the inventor of semiconductor based genomic analysis technologies, and the developer of a new, game-changing test for diagnosis of bloodstream infections that can lead to sepsis, previews its LiDia™ bloodstream infection (BSI) test today at the ‘Technology vs Infectious Diseases’ Summit held at the Royal Institution in London.

Sepsis kills around 6 million people worldwide every year. In the UK alone the number reaches 44,000 which is more than bowel, breast, and prostate cancer combined. Treatment in the early stages is crucial so there is an urgent need for early diagnosis through rapid tests.

Organised by Imperial College and the Royal Institution (Ri), the Summit highlights the best of British technology in the fight against the global threat of infectious diseases. An afternoon of presentations showcasing how cutting-edge UK research and pioneering technological solutions are contributing to tackling infectious diseases and antimicrobial resistance worldwide. An evening event featuring a keynote address by Prof David Heymann, Professor of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine; Head of the Centre on Global Health Security at Chatham House, London; and former Chairman of Public Health England, UK.

DNAe’s Chief Scientific Officer, Mr David Davidson, presented during the Summit programme on ‘Infectious Disease Diagnostics using Third Generation Sequencing on a Microchip’.

Professor Chris Toumazou, Regius Professor of Engineering at Imperial College, Trustee of the Royal Institution, and Founder and Executive Chairman of DNAe, commented: “It is an honour to be pioneering ground-breaking third generation semiconductor DNA analysis technology. We are especially pleased to preview our breakthrough genomic analysis test for diagnosis of bloodstream infections, at the historic Ri building – where Michael Faraday undertook his experiments around semiconductor properties, and where the father of antibiotics, Alexander Fleming, presented to the Ri in 1953. Innovation is a long road, so it’s exciting to be close to launch with a world-leading technology that has the potential to transform the clinical management of sepsis.”

DNAe’s LiDia™ BSI is a rapid test for serious bloodstream infections leading to sepsis. At launch, the LiDia™ BSI Test is designed to enable the precise identification of the infecting organism directly from an unprocessed blood sample within 3 hours, arming clinicians with the information that they need to provide swift treatment with the right antimicrobial drugs. Quick and appropriate treatment is the key to achieving the best prognosis for patients. Currently accurate diagnosis can take several days.

“DNAe is currently testing our end-to-end LiDia™ BSI test using clinical samples and will be presenting results at the Association for Molecular Pathology meeting (AMP) in Salt Lake City, USA in November. The Company plans to apply for CE mark approval in 2018, to enable us to bring this urgently needed test to market in Europe” said DNAe’s Group Chief Executive Officer Dr Steve Allen.

Underlining the world-leading nature of DNAe’s innovation and the game-changing nature of its semiconductor DNA genomic analysis technologies, the US BARDA has awarded the company up to $51.9m to develop its sequencing platform for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza. The Company is also exploring applications in diagnosis of cancer from liquid biopsies.

—Ends—

​

Professor Chris Toumazou, Regius Professor of Engineering at Imperial College, Trustee of the Royal Institution, and Founder and Executive Chairman of DNAe, with a semiconductor DNA sequencing chip. Copyright DNA Electronics.

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 13 September 2017 – DNAe, the inventor of next generation semiconductor DNA sequencing technology and developer of a new, game-changing test for bloodstream infections, announces that its CBO, Nick McCooke presented an update on its first product, the LiDia™ bloodstream infections (BSI) test, and outlined DNAe’s pipeline of genomic-based tests at BioCentury’s 24th Annual Newsmakers in the Biotech Industry. The conference took place on the 8th September 2017 in New York.

Commenting on DNAe’s position in the fast-growing diagnostics market, Mr McCooke said, “Our use of semiconductor-based genomic analysis sets us apart from other molecular diagnostics companies by combining the analytical power of next generation sequencing (NGS) technologies with the speed of multiplexed PCR platforms. This is critical to facilitating the integration of genomic technologies into the everyday workflow of physicians and hospitals, and will have a profound impact on how patients are treated.”

DNAe’s genomic analysis platform, LiDia™, is based on the invention of semiconductor DNA sequencing by serial technology innovator and DNAe’s founder and Executive Chairman, Professor Chris Toumazou and his team. DNAe has further developed semiconductor technology to enhance its utility in diagnostic applications, where its analysis of DNA and RNA on microchips has the potential to transform the way patients are treated.

LiDia™ is a closed system that can be operated at the clinical point-of-need, with no laboratory services or specialist training required. It is able to deliver accurate results in less than three hours, direct from blood (or other sample material), providing treating physicians with valuable intelligence to help treat their patients.

The first test available on the LiDia™ platform will be the LiDia™ bloodstream infection (BSI) test, a rapid blood-to-result diagnostic for use in the management of sepsis. LiDia™ BSI offers a significant reduction in time-to-result compared to the current standard of culture-based diagnosis, which requires a microbiology lab and generally several days to produce a result. Uniquely, LiDia™ BSI will test for both bacterial and fungal pathogens with a single test, as well as testing for antimicrobial resistance.

Privately held, DNAe has strong financial backing from its major shareholder, Genting Berhad. A Malaysian-based global investor, Genting Berhad has invested in a portfolio of cutting–edge life sciences companies that includes Synthetic Genomics and Human Longevity.

In September 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe $51.9m in non-dilutive funding to further develop its diagnostic technology to address two global health threats; AMR and pandemic Influenza. DNAe’s is the first ever next generation sequencing platform to receive funding from BARDA.

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a ground-breaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

About NewsMakers in the Biotech Industry

NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

DNAe to present its NGS Diagnostics Pipeline at 24th Annual Newsmakers in the Biotech Industry

London, UK and Carlsbad, CA, USA – 12 July 2017 - DNA Electronics (‘DNAe’), the inventor of semiconductor DNA sequencing technology and developer of a new, revolutionary sample-to-result diagnostic platform to rapidly determine the causative agent of infectious diseases, provided an update on its LiDia™ test for serious bloodstream infections (BSI), a condition which can lead to the potentially life-threatening complication of sepsis if not diagnosed and treated quickly. The test is on track for commercial launch in 2018.

Presentation

Time: 10:30 am - 10:55 am

Location: room 402/403, Millennium Broadway Hotel & Conference Center

Breakout session

Time: 11:00 am - 11:30 am

Location: room 401, Millennium Broadway Hotel & Conference Center

Nick McCooke will be available to meet whilst at the event. To arrange a time, email contact@DNAe.com or use the conference partnering system.

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

About NewsMakers in the Biotech Industry

NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

London, UK and Carlsbad, CA, USA – 12 July 2017 - DNA Electronics (‘DNAe’), the inventor of semiconductor DNA sequencing technology and developer of a new, revolutionary sample-to-result diagnostic platform to rapidly determine the causative agent of infectious diseases, provided an update on its LiDia™ test for serious bloodstream infections (BSI), a condition which can lead to the potentially life-threatening complication of sepsis if not diagnosed and treated quickly. The test is on track for commercial launch in 2018.

“Sequencing-related technologies have moved on rapidly from their use as research tools, with improvements now enabling real-life application in clinical settings. Bringing genomics and DNA sequencing closer to the patient will be transformative to the way that patients are treated, arming doctors with the information they need to make an informed decision when prescribing drugs. This not only leads to better outcomes for patients, but will help to curb the increase in antimicrobial resistance by fundamentally changing the way antibiotics are prescribed. Our LiDia BSI test for bloodstream infection is one of the first examples of a near-to-patient test that will enable swift treatment with the right antimicrobial drug.” said Nick McCooke, DNAe Group’s Chief Business Officer, during a presentation today at the Molecular Diagnostics World Summit 20171.

DNAe’s pioneering work in bringing DNA sequencing into the clinical setting, is an example of where the UK has the potential to lead the way in genomics – as highlighted last week by Prof Dame Sally Davies, UK’s Chief Medical Officer in her report Generation Genome2.

During his career, Mr McCooke led the British company that pioneered next-generation-sequencing (NGS) in the early 2000s, which has been fundamental in enabling the genomics revolution. He is now CBO at DNAe, which is commercialising semi-conductor sequencing. It is poised to lead the next step-change in DNA sequencing, bringing DNA sequencing into the near-to-patient clinical setting, by enabling the whole process of a DNA-based diagnostic test to be miniaturized and fully contained with clinically actionable results in just a few hours.

DNAe's LiDia test for BSI overcomes many of the challenges currently associated with implementing near-to-patient genomic analysis as a routine diagnostic approach. It can be performed by non-specialists, enabling 24/7 use in healthcare settings such as hospitals. Results can be used to inform treatment decisions directly, without the need for any 'wet' microbiology labs or any additional analysis. The blood sample is fully contained in a sealed, disposable cartridge to avoid potential for contamination.

In the UK, sepsis results in 44,000 deaths every year, more than bowel, breast and prostate cancer combined. Because treatment in the early stages of sepsis is so crucial to outcome and mortality rate, there is an urgent need for new, rapid diagnostics.

In September 2016, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to further develop LiDia™ for rapid diagnosis in two applications; antimicrobial resistant infections and influenza. DNAe’s is the first NGS platform supported by BARDA, marking its game-changing potential in the diagnosis and treatment of infectious diseases.

Lord O’Neill in his final report and recommendations on combatting antibiotic resistance, published in May 2016, highlighted the need for faster more accurate diagnostics in tackling this global threat saying “Most casual, and some very informed, observers automatically think the main part of the problem is getting new drugs. At least as big, if not bigger, is reducing the demand side, of which state-of-the-art diagnostics is front and center.”3

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Carlsbad, CA, USA – 18 May 2017 - DNA Electronics (‘DNAe’), the inventor of semiconductor DNA sequencing technology and developer of a new, revolutionary blood-to-result test for bloodstream infections, announces that an article on research utilizing the Company’s patented semiconductor DNA analysis technology has achieved recognition as one of the top 100 read articles for 2016 in Scientific Reports, a peer reviewed journal from the publishers of Nature.

Research carried out by scientists at Imperial College, London (within the Division of Infectious Diseases and the Department of Bioengineering) and supported by DNAe, uses a novel approach for detecting the amount of virus present in the blood of HIV patients. If successfully developed into a test, it could in the future enable HIV patients to monitor their response to treatment, and provide an early alert to the patients and their doctors to the development of drug-resistance.

The article, entitled ‘Novel pH sensing semiconductor for point-of-care detection of HIV-1 viremia’ was published on 10th November 20161. In November and December, the paper received 8,628 views, placing it within the top 100 most read of more than 20,000 articles published in Scientific Reports last year.

The research involved analysis of 991 clinical samples, showing the method using DNAe’s technology had a high level of sensitivity (95%) and an average time to result of 20.8 minutes. Currently marketed tests take three or more days to detect the amount of HIV virus present in the blood, providing a strong indication of the very rapid performance of the underlying semiconductor DNA analysis technology, Genalysis®. This is a potential new application of Genalysis®, already being developed by DNAe for the diagnosis of serious bloodstream infections leading to sepsis, antimicrobial resistant infections and influenza2.

Earlier this year, DNAe expanded its US operations and appointed four members to a newly formed Clinical Advisory Board in preparation for the launch of its first product, the LiDia™ Bloodstream Infection (BSI) Test. The test is being commercialized to address the urgent unmet need for a diagnostic capable of diagnosing the microbial cause of bloodstream infection leading to sepsis quickly and accurately. Responsible for over 200,000 deaths per annum in the US3, and 44,000 in the UK4, sepsis claims more lives than bowel, breast and prostate cancer combined4. Rapid diagnosis and treatment with the correct antibiotic can significantly reduce mortality rates. Unlike current blood culture based diagnostics which can take two to six days, the LiDia™ test for bloodstream infection will offer a ‘blood-to-result’ readout in just a few hours.

Following its test for bloodstream infections, DNAe plans to expand the range of diagnostic tests available on the LiDia™ platform to include other disease areas where rapid diagnosis is a key factor in success of treatment.

DNAe’s Founder and Executive Chairman, and Regius Professor at Imperial College London (Department of EEE) Professor Chris Toumazou (FRS, FREng, FMedSci) commented: “It is a great achievement for the whole team at Imperial and DNAe to have the article placed in Scientific Reports’ top 100 read list for 2016, and is a demonstration of the power and utility of DNAe’s technology. At DNAe, our focus is on applying our semiconductor sequencing and other technologies to address significant global threats to health, where treatment is time-critical and needs to be right first time.”

Dr Steve Allen, CEO of DNAe Group Holdings commented: “The popularity of this article is a fantastic recognition for the team at Imperial, supported by our scientists, and is testament to the importance of the work they’re doing. This is a further example of the breadth of application of DNAe’s technology. We wish the Imperial team every success as they develop their research further.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza

London, UK and Carlsbad, CA, USA – 6 March 2017 – DNA Electronics (‘DNAe’), the inventors of semiconductor DNA sequencing technology and developers of a new, revolutionary blood-to-result test for bloodstream infections, announces the formation of its clinical advisory board (CAB). The CAB, with founding members Professor Paul Dark, Professor Angela Caliendo, Professor Stephan Harbarth and Professor Romney Humphries, brings together US and European experts to provide strategic guidance for the clinical development of DNAe’s diagnostic platform, LiDia™, and its accompanying range of tests for different clinical applications.

“As we continue the commercialization of our technology and prepare for the launch of our first product, the LiDia™ Bloodstream Infection (BSI) Test, it is important that we work closely with experts to ensure that our products are aligned with hospital practice and best serve the medical need” said Dr Steve Allen, CEO of DNAe Group Holdings.

Regius Professor Chris Toumazou, FRS, FREng, FMedSci, Founder and Executive Chairman of DNAe Group Holdings added: “The members of our new Clinical Advisory Board are each highly esteemed in their respective fields. They bring a range of expertise and clinical specialisms including clinical microbiology, sepsis, point-of-care diagnostics, critical care and hospital epidemiology, providing a perfect fit to our work in developing fast and powerful genomic tests for infectious diseases. We welcome their critical contribution to our product development and are confident they will contribute positively to our mission to bring cutting edge near-patient technology to the early diagnosis and monitoring of life threatening diseases.”

The board is formed of the following distinguished academic clinicians:

Professor Paul Dark, BSc, MD, PhD, FRCS, FRCEM, FFICM

Professor Dark is Chair of Critical Care Medicine at the University of Manchester, UK, where he is responsible for developing postgraduate learning in research and innovation in acute healthcare. He is a senior clinical academic at the University, carrying out his duties as an NHS consultant in Critical Care Medicine at the Salford Royal NHS Foundation Trust. He is also a National Research Lead in Critical Care for the National Institute of Health Research (NIHR) and Visiting Professor at King’s College London. He leads a program of work funded by the NIHR, developing and assessing the diagnostic utility of emerging molecular technologies in the setting of sterile tissue injury and severe infection - focused on matrices in blood and breath. He has also led a program funded by Innovate UK, developing novel technologies aimed at rapid point-of-care infection/sepsis diagnosis. He advises NICE on diagnostic technology appraisals in sepsis and leads multi-center pragmatic clinical trials aimed at developing an improved evidence base for the management sepsis.

Professor Angela Caliendo, MD, PhD, FIDSA

Dr Caliendo is Professor, Executive Vice Chair of the Department of Medicine, and Director of the Division of General Internal Medicine at the Warren Alpert Medical School of Brown University, USA. She is an Editor for the Journal of Clinical Microbiology, Chair of the Microbiology Medical Devices Panel for the FDA and was Chair of the Diagnostics Task Force for the Infectious Diseases Society of America and is currently on the Board of Directors for the Infectious Diseases Society of America. Dr. Caliendo’s research has focused on the development of molecular diagnostic tests for the detection and quantification of infectious diseases and assessment of their clinical utility.

Professor Stephan Harbarth, MD, MS

Dr Stephan Harbarth is Associate Professor the University of Geneva, Switzerland and Senior Consultant at Geneva University Hospitals. His group is currently conducting several clinical and epidemiological studies to evaluate key questions related to the control of the acquisition, transmission and infection by multidrug-resistant microorganisms. It is also participating in several ongoing large-scale EU-funded studies to address this public health threat and collaborating closely with the Genomics Research Laboratory at HUG (University of Geneva Hospitals), based on a productive translational research platform.

Professor Romney Humphries, PhD, D(ABMM), M(ASCP)CM

Dr Humphries is an Assistant Professor in the Department of Pathology and Laboratory Medicine in the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), USA. She is the Section Chief for Clinical Microbiology at UCLA Health and Chief Quality Officer for the Department of Pathology & Laboratory Medicine. Dr Humphries’ research focus is the detection and characterization of emerging antimicrobial resistance in bacteria, and the development of next generation diagnostic technologies. She is a member of the Clinical and Laboratory Standards Institute (CLSI) Antimicrobial Susceptibility Testing (AST) Subcommittee and Microbiology Resource Committee for the College of American Pathologists.

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Feb 22, 2017 | DNAe announces opening of US facility, expansion of operations and launches product brand as it prepares for commercialization

DNAe announces opening of US facility, expansion of operations and launches product brand as it prepares for commercialization

• New California-based clinical diagnostic development and manufacturing facility opened

• Diagnostic platform named as LiDia™

London, UK and Carlsbad, CA, USA – 22 February 2017 – DNA Electronics (‘DNAe’), the inventors of semiconductor DNA sequencing technology and developers of a new, revolutionary blood-to-result test for bloodstream infections, announces the opening of its new US facility in preparation for commercializing its first product. DNAe also announces its new brand identity.

Expansion of US operations

Located in Carlsbad, California, DNAe’s new site expands its operations in the US and provides a specialized development and manufacturing base for its first product under the LiDia™ brand. The facility was officially opened by the Mayor of Carlsbad, Matt Hall and Councilman Michael Schumacher with a ribbon-cutting ceremony on 21st February 2017.

Housing 15,000 square feet of laboratories including specialized cleanrooms and 9,000 square feet of office space, the Carlsbad site currently employs 38 people following relocation from the Company’s previous facility in Albuquerque, NM, with recruitment still ongoing.

An area recognized globally as a hub for life sciences and technology, Carlsbad is an ideal location for DNAe as it grows its team and positions itself for commercialization. The Carlsbad facility will play a key role in integrating DNAe’s key technologies, namely high sensitivity sample processing and rapid DNA analysis.

The Carlsbad site provides DNAe with the capacity to complete final development and begin commercial manufacture of its first test for bloodstream infections.

Victor Esch, President and Chief Executive Officer, DNA Electronics Inc., based at the new Carlsbad facility said: “As we prepare to begin manufacturing our lead product, our new facility in Carlsbad enables us to tap into a wide pool of local talent and world class industry partners to support the next phase in our development. With these new facilities, and our strong and growing team, we are in an excellent position to make a game-changing impact in the infectious disease diagnostics space. Our first products will specifically address the huge global need for rapid diagnostics for sepsis.”

Matt Hall, Mayor of Carlsbad commented, “Carlsbad is home to an active scientific community and we welcome DNAe, and the opportunities and skills it brings to the area.”

Diagnostic platform name announced as LiDia™

DNAe’s diagnostic platform will be named LiDia™. Based on DNAe’s Genalysis® DNA analysis technology, LiDia™ uses a combination of novel approaches, including ultra-sensitive sample preparation and semiconductor-based DNA analysis all within a single cartridge. The first LiDia™ test will be for bloodstream infection offering a broad test panel, capable of identifying the most critical suspected pathogens associated with bloodstream infections, as well as key antibiotic resistance markers.

Referred to as a ‘national epidemic’ in the US, the human cost of sepsis is enormous: there are over 1 million cases in the US each year, and 28-50% of people with severe sepsis will die. A key factor is the speed at which a patient receives the appropriate antibiotics, with the chance of mortality increasing 8% every hour that a patient in septic shock does not receive the correct antibiotic for treating the causative organism.

The LiDia™ test for bloodstream infection operates directly from blood, delivering a clinically-relevant report for the physician. Unlike current blood culture based diagnostics which can take two to six days, LiDia™ will offer a ‘blood-to-result’ readout in just a few hours.

The introduction of the platform name is accompanied by a new website and brand identity for DNAe. The new website can be accessed at www.dnae.com.

Dr Steve Allen, CEO of DNAe Group commented, “The opening of our Carlsbad facility lays the foundation for the next phase of our story, as we commercialize our technology toward market introduction of LiDia™. We are excited to be able to deliver on the extensive research and testing that has propelled us from a spin-out of Imperial College London to a company focused on improving clinical practice and patients’ lives through near-to-patient, blood-to-result rapid diagnostics.”

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA sequencing technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. Its LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system. LiDia™ can operate in a variety of hospital environments close to the point of need with flexible levels of throughput to match a wide range of clinical demands. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis.

A private company, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Presented by electronics industry magazine Electronics Weekly, the award recognises Professor Toumazou’s pioneering career founded on his visionary application of electronic engineering to solve complex biological problems. His achievements have included the invention and roll-out of several life-changing products based on semiconductor technology, such as miniature cochlear implants and an artificial Pancreas.

Professor Toumazou’s invention of semiconductor genomic analysis has revolutionised next generation sequencing in laboratories around the world. DNAe was founded to develop this Genalysis® technology for use in rapid diagnostics with its first product being a ground-breaking test for serious blood infections leading to sepsis, an area of huge unmet medical need.

At launch in 2018, the test will apply the powerful diagnostic capability into a rapid, user-friendly format. Unlike existing approaches, the platform operates directly from blood, without the need for a blood-culture step and dramatically reduces the wait for results, a key advantage when even an hour’s delay in treatment can significantly increase mortality rates.

The technology is set to transform how patients with serious bloodstream infections are treated by not only enabling the rapid matching of the right drug to a patient, but also supporting the fight against antimicrobial resistance by enabling the clinician to prescribe the right antibiotic first time.

Commenting on the award, Professor Toumazou said: “It is an honour to receive this Lifetime Achievement Award and such recognition from the electronics community. DNAe embodies the values that have driven my career; identifying and applying a novel technology to tackle areas of medical need, where its benefits can sometimes be the differentiating factor between life and death. I have always wanted to apply my invention of semiconductor-sequencing in a domain where rapid results and ease of use are important, and in the medical sector, diagnosis of infectious diseases like sepsis is a perfect application. It is fantastic to receive a Lifetime Achievement Award, but with so many other possible applications for this technology, I’m not done yet!”

Dr Steve Allen, CEO of DNAe said, “The potential for Chris’ inventions is significant and he has already made a huge positive impact on many thousands of patients. At DNAe we are working to realise the potential of semiconductor-based genomic technology to revolutionise diagnosis of conditions such as sepsis, pandemic influenza and antimicrobial resistance, demonstrating its versatility and performance, and hopefully saving lives as a result.”

In September 2016, DNAe secured a $51.9m contract from the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to develop Genalysis® for rapid diagnosis in a further two key applications; antimicrobial resistant infections and influenza. It is the first next generation sequencing platform (NGS) platform supported by BARDA.

Professor Toumazou and his invention of semiconductor-based next-generation DNA sequencing was also recognised by the European Patent Office’s 2014 European Inventor Award for Research, the Institution of Engineering and Technology’s highest accolade, the Faraday Medal, and the Royal Society’s Gabor Medal in 2013.

DNAe is commercialising its pioneering semiconductor DNA analysis technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling early administration of appropriate treatment.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics, Inc.), a developer of a novel and highly sensitive system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA analysis technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. DNAe’s first product will be a diagnostic test for bloodstream infections for use in the management and prevention of sepsis. In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza.

A private company, with operations in London, UK, and Carlsbad, CA and Washington, DC, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Professor Toumazou’s research is dedicated to saving and improving lives through the invention of revolutionary, innovative and disruptive technologies, including the creation of a leading edge medical research institute as well as four spin-out ventures to commercialise his ground-breaking inventions.

Chris is London’s first Regius Professor of Engineering, at Imperial College London where he holds a Chair in Biomedical Circuits in the Department of Electrical and Electronic Engineering. He is also Director of the Centre for Bio-Inspired Technology, Founder and Chief Scientist of the Institute of Biomedical Engineering, and Executive Chairman of DNAe. DNAe is developing rapid diagnostics for life-threatening infectious diseases, based on Chris’ semiconductor DNA sequencing technology. In recognition of this invention he won the 2014 European Inventor Award from the European Patent Office, the Institute of Engineering and Technology’s highest accolade, the Faraday Medal and the IEEE Field Medal for Bio-Engineering, both in 2015. In 2013, he was awarded the Royal Society Gabor Medal.

Dr Steve Allen, CEO DNAe Group Holdings said: “AMP 2016 is a greatly respected conference and an ideal place for us to present data on our complete end-to-end workflow for the first time. This includes bacterial, fungal and antibiotic resistance gene targets at low limits of detection. Our Genalysis® platform for serious bloodstream infections (G-BSI) detects and identifies pathogens directly from whole human blood”.

“Referred to as a ‘national epidemic’ in the US, the human cost of sepsis is enormous: there are over 1 million cases in the US each year, and 28-50% of people with severe sepsis will die. A key factor is the speed at which a patient receives the appropriate antibiotics, with the chance of mortality increasing 7.6% every hour that a patient in septic shock does not receive the correct treatment. Compared to current tests, which can take up to three days, G-BSI will enable a turnaround time of just a few hours, addressing a huge and urgent unmet need.”

DNAe’s G-BSI test uses a combination of novel technologies, including ultra-sensitive sample preparation to remove the time-consuming blood culture step, and semiconductor-based real time PCR for rapid pathogen detection. This allows the test to identify the most prevalent causes of bloodstream infections and key antibiotic resistance markers within just a few hours of sample presentation. The test can be performed by non-specialist laboratory personnel and simply requires a standard 10 mL blood collection tube containing the sample to be slotted into a cartridge, which is then inserted into the instrument.

Regius Professor Chris Toumazou, Founder and Executive Chairman, DNAe Group Holdings, said: “This data will demonstrate both the great progress being made in the development of our G-BSI test, and the suitability of DNAe’s semiconductor-based DNA analysis technology for the diagnosis of sepsis, where time to result is a critical factor in reducing mortality. This is a testament to the platform, the team and the strategy we have in place to revolutionise how serious bloodstream infections are diagnosed and treated.”

DNAe is commercialising its pioneering semiconductor DNA analysis technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling early administration of appropriate treatment.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics, Inc.), a developer of a novel and highly sensitive system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA analysis technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. DNAe’s first product will be a diagnostic test for bloodstream infections for use in the management and prevention of sepsis. In October 2016, the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) awarded DNAe a contract worth up to $51.9 million to develop Genalysis® for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza.

A private company, with operations in London, UK, and Carlsbad, CA and Washington, DC, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

• First next-generation sequencing platform to receive funding from BARDA

• Up to $51.9 million, contract to support testing and FDA clearance of DNAe’s sequencing platform for a series of applications

• Initial focus to address two of the most significant threats to global health, antimicrobial resistance and influenza

London, UK and Carlsbad, CA, USA – 30 September 2016 DNA Electronics (‘DNAe’), the inventors of semiconductor-based next-generation DNA sequencing (NGS) technology and developers of a revolutionary blood-to-result test for bloodstream infections, announces that the Biomedical Advanced Research and Development Authority (BARDA) a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) has awarded the Company a contract worth up to $51.9 million to develop its sequencing platform for rapid diagnosis in two key applications; antimicrobial resistant infections and influenza.

Genomic information derived from DNA sequencing is transforming many areas of medicine. This is the first NGS platform supported by BARDA, with game-changing potential in the diagnosis and treatment of infectious diseases.

The Centers for Disease Control and Prevention (CDC) have estimated that more than 2 million people per year in the U.S. suffer antimicrobial resistant infections resulting in 23,000 deaths. The CDC also predicts that a flu pandemic could result in between 89,000 and 207,000 deaths in the U.S. and could cost the economy $71.3-166.5 billion.

The contract for the project entitled PISCES (Pathogen Identification from Specimen, via Capture Extraction and Sequencing) will enable DNAe to complete the development and validation of its ground-breaking Genalysis® platform and support a series of applications to the U.S. Food and Drug Administration for marketing clearance.

The Genalysis® platform will combine the ability to sequence the DNA of the infectious organism, in a sealed microchip based system, direct from clinical specimen, with analysis that enables actionable identification of the disease agent within a few hours, a key requirement in the effective treatment of infectious diseases.

DNAe’s first product will be a rapid blood-to-result diagnostic system to meet an unmet need in the treatment of serious bloodstream infections leading to sepsis. Sepsis is an area of very high unmet medical need, responsible for over 200,00 deaths per annum in the US, more than prostate cancer, breast cancer and AIDS combined1. In late stage development and testing, the new system is set for commercial launch in 2018.

In 2014, BARDA awarded a $21.5 million, contract to DNAe’s US operation (then called nanoMR, Inc.) to develop an automated sample preparation system that could reduce the time needed to test for bloodstream infections and biothreat agents such as anthrax from days to hours. DNAe acquired nanoMR in January 2015 to complete the workflow of its sample-to-result solution by combining nanoMR’s novel Pathogen Capture System, which extracts and concentrates pathogens, such as bacteria or fungi directly from a raw blood sample, with its Genalysis® technology.

Sam Reed, President, U.S. Office, DNAe, based in Washington DC, and who is leading DNAe’s sequencing program commented: “Our platform is truly revolutionary as it brings a powerful sequencing-based diagnostic capability into a rapid, user-friendly format. Importantly the platform can be operated by users who are not specially-trained in sequencing, enabling it to be used in a wide range of near-to-patient clinical environments where sequencing has not been possible before. Unlike existing sequencing devices, the platform operates ‘push button’ directly from raw clinical specimens such as blood or swabs, delivering a clinically-relevant report for the physician.”

Bloodstream infections afflict over 1 million patients per year in the US alone, making it the single most expensive disease in terms of total healthcare expenditure2. DNAe’s Genalysis® platform will revolutionize care by very rapidly identifying the causative pathogens and their antibiotic resistance profile from a wide range of potential causes. This has the potential to drive reduced mortality, reduced length of stay in critical care, reduced healthcare expenditure, and improved management of antibiotics. In influenza testing, the platform has the potential to ultimately identify the strain subtype and antiviral resistance markers, guiding antiviral usage in critical patients or for management of patients during a pandemic.

Dr Steve Allen, CEO DNAe Group Holdings said: “DNA sequencing-based tests that can rapidly provide accurate diagnostic information on infectious diseases will be a game-changer in terms of how clinicians treat infectious diseases in the future. It will enable the choice of treatment to be highly specific and tailored to the causative pathogens. Antimicrobial resistance and the threat of an influenza pandemic are two of the most critical threats to human life, and areas of huge unmet need. The support and cooperation of the U.S. Government will be instrumental in our mission to provide rapid diagnostics to support healthcare professionals, enabling a more effective public health response to these crises.”

Semiconductor-based DNA sequencing was invented by DNAe’s Founder, Executive Chairman, and Regius Professor at Imperial College London (Department of EEE), Professor Chris Toumazou and his group at Imperial. A highly acclaimed serial entrepreneur, this invention has earned him the UK Institution of Engineering and Technology (IET)’s highest honour, the Faraday Medal and the European Patent Office’s prestigious Inventor of the Year Award for Research in 2014, and the Gabor Medal of the Royal Society in 2013. DNAe owns and applies his patented technology to create rapid diagnostics that address critical unmet needs in healthcare applications. The semiconductor sequencing technology is licensed to Thermo-Fisher for research use.

Professor Toumazou, DNAe said: “This collaboration demonstrates the suitability of DNAe’s NGS-based platform to address a range of clinical needs, demonstrated by the applications in antimicrobial resistance and influenza testing, where there is a very high unmet need.”

DNAe is commercialising its pioneering semiconductor DNA analysis technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA analysis technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. DNAe’s first product, will be a diagnostic test for bloodstream infections for use in the management and prevention of sepsis.

A private company, with operations in London, UK, and Carlsbad, CA and Washington DC, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

Dec 4, 2015 | DNAe Expands US Operations with Clinical Diagnostic Development and Manufacturing Site in San Diego

DNAe Expands US Operations with Clinical Diagnostic Development and Manufacturing Site in San Diego

Relocation from current site in Albuquerque will double headcount and ideally positions DNAe for the launch of its Genalysis® platform and bloodstream infection assays

London, UK and Albuquerque, NM, USA – 4 December 2015 DNA Electronics (‘DNAe’), the inventors of semiconductor DNA sequencing technology and developers of a new, revolutionary point-of-need test for bloodstream infections, will expand and relocate its US operations from Albuquerque, NM to San Diego, CA. The move is expected to be completed by the end of 2016.

Located in an area recognized globally as a hub for life sciences and technology, DNA Electronics Inc. will be ideally situated to grow its experienced team. The relocation to San Diego is essential as DNAe enters the final development and manufacturing stages for launch of its rapid point-of-need in vitro diagnostic (IVD) for bloodstream infections. The Company intends to expand capacity significantly, increasing its US-based headcount from 29 to over 50 and building a specialized clinical diagnostic manufacturing facility, clinical testing laboratories and a commercial team.

DNA Electronics Inc. (previously nanoMR Inc.) was founded in 2006 as a spin-out of the University of New Mexico. The Company, which has developed novel Pathogen Capture System technology, was acquired by UK-based DNAe in January 2015. DNAe is integrating its Genalysis® semiconductor DNA sequencing technology with this Pathogen Capture System to develop an IVD for serious blood infections that lead to sepsis.

Victor Esch, Chief Executive Officer, DNA Electronics Inc. said: “Albuquerque has been a fantastic place to build our innovation-led business and develop our technology over the past decade. As we transition into our next stage of development, building our operations towards the launch of our pioneering test for serious blood infections, San Diego offers us the opportunity to expand our workforce and exploit opportunities within the San Diego life sciences hub.

“The new site will be close to our major development partners and suppliers, the clinical diagnostic expertise to grow our team further and great transport links which positions us ideally for forthcoming clinical trials and manufacturing. We are proud of our heritage and will be maintaining strong links with our partners in Albuquerque including with the University of New Mexico and TriCore Reference Laboratories.”

Prof. Chris Toumazou, Executive Chairman, DNAe said: “We are making great progress in the development of our bloodstream infections test and, with our £25 million Citibank facility in place, we have the finances to enable us to invest in the staff, R&D and facilities needed as we progress rapidly towards the launch of our first test system in 2017.

“The expansion of US operation is central to achieving this objective, and to bringing a much needed point-of-need test to the infectious disease management setting. We look forward to completing clinical development and to begin manufacturing on-site.”

The increase in capacity will create skilled job opportunities in specialty manufacturing, clinical development, regulatory and commercial positions. All existing staff at the Albuquerque site have been offered roles in San Diego with most expected to relocate throughout 2016.

DNAe is commercialising its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA sequencing technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. DNAe’s first product, will be a diagnostic test for bloodstream infections for use in the management and prevention of sepsis.

A private company, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK and Albuquerque, USA – 2 November 2015 DNAe, the inventors of semiconductor DNA sequencing technology, have secured a bank facility of £25 million ($38 million) to fund the final development stages of DNAe Diagnostics’ revolutionary point-of-need test for serious blood infections. This will include clinical trials targeted for 2016 and product launch in 2017.

The facility, with Citibank, follows an internal fundraising exercise that raised $24 million in January 2015 to fund DNAe’s acquisition of Albuquerque, USA-based nanoMR, Inc. (now DNA Electronics, Inc.).

DNAe is applying its Genalysis® semiconductor DNA sequencing technology to develop a rapid in vitro diagnostic for serious blood infections that lead to sepsis. The test integrates DNA Electronics Inc.’s novel Pathogen Capture System technology with DNAe’s Genalysis® platform, to provide a complete blood-to-result diagnostic solution with actionable results in 2-3 hours. This is a major step forward from current approaches, which can take days, in an area where time-to-result is a critical factor.

Prof. Chris Toumazou, Executive Chairman, DNAe said: “The development of our serious bloodstream infections test is progressing well. Following the acquisition and integration of nanoMR, Inc. earlier this year, we are in a great position to achieve our objective to launch our in vitro diagnostic system in 2017. Our semiconductor DNA semiconductor technology has the potential to revolutionise how patients with these life-threatening infections are treated and the bank facility demonstrates the confidence of the bank and of our shareholders in DNAe’s technology, team and strategy to achieve this.”

DNAe is commercialising its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample to result genomic analysis platform combining DNA Electronics Inc.’s Pathogen Capture System with its own Genalysis® semiconductor DNA sequencing technology. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. DNAe’s first product, will be a diagnostic test for bloodstream infections for use in the management and prevention of sepsis.

A private company, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

London, UK – 27 May 2015 DNA Electronics (‘DNAe’), the inventors of semiconductor DNA analysis technology and developers of a new, revolutionary point-of-need test for serious blood infections, congratulate its founder and Chairman Professor Chris Toumazou who accepted the Institute of Electrical and Electronics Engineers’ (IEEE) prestigious 2015 Field Medal in Biomedical Engineering last night. Professor Toumazou’s research is dedicated to saving and improving lives through the invention of revolutionary, innovative and disruptive technologies.

The award was presented by IEEE President and CEO, Howard E. Michel at a ceremony during the 2015 International Symposium on Circuits and Systems (ISCAS) in Lisbon. It recognises Professor Toumazou’s contributions to biomedical circuit technology which includes the invention of semiconductor DNA analysis and its ability to revolutionise healthcare and save lives.

Commenting on the award Professor Toumazou said: “My research is driven by an acute awareness of areas of unmet medical need, and in identifying how electronic inventions can help. The ability to reduce time to diagnosis in serious blood infections from days to just a few hours using our semiconductor DNA analysis platform can mean the difference between life and death for some patients. I am honoured that the IEEE has recognised my work. ”

Semiconductor DNA analysis converts a natural biochemical reaction to an electrical signal. Unlike other DNA analysers, the technique does not require bulky optical systems to look at unnatural fluorescent dyes fixed to DNA molecules, and offers major benefits of rapidity, economy and compact DNA analysis. Since 2010, under license from DNAe, semiconductor DNA sequencing has been used in laboratories all over the world and forms the core of Thermo Fisher’s Ion Torrent™ bench-top DNA sequencer.

Professor Toumazou’s invention of semiconductor DNA sequencing was recognised by the European Patent Organisation’s 2014 European Inventor Award for Research, the Institution of Engineering and Technology’s highest accolade, the Faraday Medal, and the Royal Society’s Gabor Medal in 2013.

DNAe is developing semiconductor DNA analysis technology for use in a pioneering rapid test for serious blood infections leading to sepsis. The test will integrate novel sample preparation technology recently acquired via its acquisition of Albuquerque-based nanoMR Inc. to provide a complete blood-to-result diagnostic solution with actionable results in 2-3 hours. This is a major step forward from current approaches which can take days, in an area where time-to-result is a critical factor.

Professor Toumazou’s other ‘medical microchip’ inventions include the world’s first totally implantable cochlear prosthetic for born-deaf children and the first wireless healthcare patch to monitor patients’ vital signs remotely, allowing them to be discharged from hospital.

IEEE President and CEO, Howard E. Michel said: "Professor Toumazou is an engineer who has developed numerous medical devices that have revolutionised healthcare. The IEEE is the world's largest professional association dedicated to advancing technological innovation for the benefit of humanity and Professor Toumazou's work was a stand-out contender for the Biomedical Engineering Award in what was a very competitive field."

DNA Electronics Ltd (‘DNAe’) is commercialising its pioneering semiconductor DNA analysis technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

Through a non-exclusive license to Thermo Fisher, the performance of DNAe’s semiconductor DNA sequencing technology has been proven as the core of the Ion Torrent™ Next Generation Sequencing (NGS) system.

In January 2015 DNAe acquired nanoMR Inc. a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing a complete sample-to-result genomic analysis platform combining nanoMR’s Pathogen Capture System with its own Genalysis® semiconductor DNA analysis technology. Built into a compact device for use at the point-of-need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease. DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. The Company’s first test will be a diagnostic for blood stream infections for use in the management and prevention of sepsis.

Professor Toumazou’s research is dedicated to saving and improving lives through the invention of revolutionary, innovative and disruptive technologies, including the creation of a leading edge medical research institute as well as spin-out ventures to commercialise his ground-breaking inventions namely DNA Electronics Ltd (DNAe), GENEU and Toumaz Group plc.

Chris is London’s first Regius Professor of Engineering, at Imperial College London where he holds a Chair in Biomedical Circuits in the Department of Electrical and Electronic Engineering. He is also Director of the Centre for Bio-Inspired Technology, Founder and Chief Scientist of the Institute of Biomedical Engineering, and Chairman of DNAe. DNAe is developing point-of-need diagnostics for life-threatening infectious diseases, based on Chris’ semiconductor DNA sequencing technology. In recognition of this invention he recently won the 2014 European Inventor Award from the European Patent Office, the Institute of Engineering and Technology’s highest accolade, the Faraday Medal and was awarded the Royal Society Gabor Medal 2013.

DNAe to present its NGS Diagnostics Pipeline at 24th Annual Newsmakers in the Biotech Industry

London, UK and Albuquerque, NM, USA – 19 January 2015 - DNAe, the inventor of semiconductor DNA sequencing technology and developer of a new, game-changing test for bloodstream infections, announces that its Chief Business Officer, Nick McCooke will present an update on its first product, the LiDia™ bloodstream infections (BSI) test, at BioCentury’s 24th Annual Newsmakers in the Biotech Industry on 8th September in New York. DNAe will also outline its pipeline of diagnostic tests, including applications in sepsis, antibiotic resistant infections, flu and cancer.

Presentation

Time: 10:30 am - 10:55 am

Location: room 402/403, Millennium Broadway Hotel & Conference Center

Breakout session

Time: 11:00 am - 11:30 am

Location: room 401, Millennium Broadway Hotel & Conference Center

Nick McCooke will be available to meet whilst at the event. To arrange a time, email contact@DNAe.com or use the conference partnering system.

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About DNAe – www.dnae.com

DNAe is commercializing its pioneering semiconductor DNA sequencing technology for healthcare applications where rapid near-patient live diagnostics is needed to provide actionable information to clinicians, saving lives by enabling the right treatment at the right time.

In January 2015 DNAe acquired nanoMR, Inc. (now DNA Electronics Inc.), a developer of a novel system for rapid isolation of rare cells in the bloodstream. DNAe is developing LiDia™, its sample-to-result genomic analysis platform, combining DNA Electronics Inc.’s Pathogen Capture System with its own portfolio of semiconductor-based genomic technologies, trademarked Genalysis®. The LiDia™ range of tests will enable DNA analysis directly on a microchip, providing rapid and accurate results from a user-friendly system.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific information can make the difference between life and death. LiDia™ launches with the LiDia™ Bloodstream Infection (BSI) test, a groundbreaking rapid direct-from-specimen test for bloodstream infections that lead to sepsis. Built into a compact device for use at the point of need, the system will diagnose accurately and rapidly what infection a patient has, providing the clinician with actionable information to help select the appropriate antibiotics to treat the disease.

A private company, with bases in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting–edge life sciences companies.

About NewsMakers in the Biotech Industry

NewsMakers presents a hand-picked group of public biotech companies whose corporate and regulatory milestones will drive stock prices. NewsMakers is recognized as the industry's key venue for companies to take their story to Wall Street each fall. Thus, NewsMakers remains the best opportunity for business development executives and key members of the institutional investment and analyst communities to compare notes and assess the industry landscape.

Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.